NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE- norethindrone acetate and ethinyl estradiol, and ferrous fumar

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

NORETHINDRONE ACETATE (UNII: 9S44LIC7OJ) (NORETHINDRONE - UNII:T18F433X4S), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

Dostopno od:

Warner Chilcott (US), LLC

INN (mednarodno ime):

NORETHINDRONE ACETATE

Sestava:

NORETHINDRONE ACETATE 1 mg

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules is indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14)] . The efficacy of norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated. Do not prescribe norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules to women who are known to have the following conditions: - A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)] Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)] Have cerebrovascular disease [see Warnings and Precautions (5.1)] Have coronary artery disease [see Warnings and Precautions (5.1)] Have thrombogenic valvular or thrombogenic

Povzetek izdelek:

Norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules is available in blister cards (dispensers) containing 28 soft gelatin capsules: Each blister card contains 28 capsules in the following order: Cartons of 5 blister cards packed individually in 5 cartons are provided for dispensing. NDC 0430-0539-50 Store at 25º C (77º F); excursions permitted to 15 to 30º C (59 to 86º F) [see USP Controlled Room Temperature]. Protect from light. Store blister card in the wallet provided in the carton when not in use.

Status dovoljenje:

New Drug Application

Lastnosti izdelka

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE-
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE
WARNER CHILCOTT (US), LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NORETHINDRONE ACETATE AND
ETHINYL ESTRADIOL CAPSULES AND FERROUS FUMARATE CAPSULES SAFELY AND
EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR NORETHINDRONE ACETATE AND ETHINYL
ESTRADIOL CAPSULES AND
FERROUS FUMARATE CAPSULES.
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL CAPSULES AND FERROUS
FUMARATE CAPSULES,
FOR ORAL USE
INITIAL U.S. APPROVAL: 1968
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WOMEN OVER 35 YEARS OLD WHO SMOKE SHOULD NOT USE NORETHINDRONE ACETATE
AND ETHINYL ESTRADIOL
CAPSULES AND FERROUS FUMARATE CAPSULES (4)
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM COMBINATION ORAL
CONTRACEPTIVE (COC) USE (4)
INDICATIONS AND USAGE
Norethindrone acetate and ethinyl estradiol capsules and ferrous
fumarate capsules is an estrogen/progestin COC
indicated for use by women to prevent pregnancy (1)
The efficacy in women with a body mass index of more than 35 kg/m has
not been evaluated (1, 8.8)
DOSAGE AND ADMINISTRATION
Take one capsule by mouth at the same time every day (2.1)
Take capsules in the order directed on the blister pack (2.1)
Capsules may be administered without regard to meals (12.3)
DOSAGE FORMS AND STRENGTHS
Norethindrone acetate and ethinyl estradiol capsules and ferrous
fumarate capsules consists of 28 soft gelatin capsules in
the following order (3):
24 yellow capsules (active), each containing 1 mg norethindrone
acetate and 20 mcg ethinyl estradiol
4 maroon capsules (non-hormonal placebo) each containing 75 mg ferrous
fumarate which does not serve any
therapeutic purpose
CONTRAINDICATIONS
A high risk of arterial or venous thrombotic diseases (4)
Breast cancer or other estrogen- or progestin-sensitive cancer (4)
Liver t